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FDA grants PolarityBio a breakthrough therapy designation for SkinTE for treating Wagner Grade 1 diabetic foot ulcers.[ Price : $8.95]
The Sedgwick full-year recall report for 2024 shows medical device recalls increasing and drug recalls decreasing.[ Price : $8.95]
Becton Dickinson recalls one lot of ChloraPrep clear 1 mL applicators due to fungal contamination concerns.[ Price : $8.95]
Supernus Pharmaceuticals says its Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a st...[ Price : $8.95]
FDA approves an ImmunityBIO expanded access program for recombinant BCG to help address a BCG shortage in treating bladder cancer.[ Price : $8.95]
Hyman, Phelps & McNamara regulatory and medical device principal expert Richard Lewis uses his experience at FDA during the 2018-2...[ Price : $8.95]
Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.[ Price : $8.95]
FDA refuses to file a Harmony Biosciences Wakix sNDA to treat excessive daytime sleepiness due to idiopathic hypersomnia.